Reuters logo
BRIEF-Stemline Therapeutics announces positive FDA meeting, agreement on expedited pathway to full approval of SL-401 in first-line BPDCN
January 5, 2017 / 10:21 PM / in a year

BRIEF-Stemline Therapeutics announces positive FDA meeting, agreement on expedited pathway to full approval of SL-401 in first-line BPDCN

Jan 5 (Reuters) - Stemline Therapeutics Inc

* Stemline Therapeutics announces positive FDA meeting and agreement on expedited pathway to full approval of SL-401 in first-line BPDCN

* BLA filing for SL-401 targeted for 2H17, with commercial launch projected for 2018

* Approximately half of new cohort patients already enrolled, with full enrollment expected this quarter

* If successful, Stemline projects a commercial launch of SL-401 in 2018

* Continue to advance SL-401 into other indications in effort to provide benefit to patients who are battling aggressive cancers

* Intends to file BLA in 2H17, which is anticipated to undergo expedited review given SL-401’s breakthrough therapy designation Source text for Eikon: Further company coverage:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below